NCT01450553

Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease

Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Precision Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals. Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater. The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.

Detailed description

Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.

Conditions

• Non-Small Cell Lung Cancer

Timeline

• Start date: 2011-10-01
• First posted: 2011-10-12
• Last updated: 2012-01-11

Locations

7 sites across 1 country: United States